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Effects of Nycthemeral Variations on CT Parameters Reflecting Airways Remodelling, and Pulmonary Emphysema Extent in COPD: Comparisons Between CT Scans Obtained in the Morning and in the Afternoon and Relationships With Pulmonary Function Tests


N/A
40 Years
N/A
Not Enrolling
Both
COPD, CT, Nycthemeron

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Trial Information

Effects of Nycthemeral Variations on CT Parameters Reflecting Airways Remodelling, and Pulmonary Emphysema Extent in COPD: Comparisons Between CT Scans Obtained in the Morning and in the Afternoon and Relationships With Pulmonary Function Tests


Patients : COPD patients aged 40 years or more, with a smoking history of > 10 pack-years
(PY), a post-bronchodilator forced expiratory volume in one second to vital capacity ratio
(FEV1/VC) < 0.7 and an optimal treatment according to GOLD guidelines will be included.
Exclusion criteria are: COPD exacerbation or respiratory infection in the 4 weeks before the
begin of the study, concomitant pulmonary disease (tuberculosis, significant bronchiectasis,
lung cancer), pulmonary resection, active malignancy or malignancy of any organ system
within the past 5 years.

Procedures: All measurements will be performed on the same day, after obtaining the written
informed consent of the patient. Medical history, smoking status and patient's treatment
will be collected.

At 08:00 AM (T0): PFT will be performed, including vital capacity (VC), forced vital
capacity (FVC), functional residual capacity (FRC), total lung capacity (TLC), residual
volume (RV), forced expiratory volume in one second (FEV1), diffusion lung capacity for
carbon monoxide (DLCO), and alveolar volume (VA) measurements (either in absolute values and
percentage of predicted values). A first CT scan will be performed using the following
technique:

- Supine CT scan after full inspiration.

- Acquisition parameters: (Topogram 35 mA 120 kV 512 mm length) 90 quality ref mAs with
care-dose ON 120 kV Pitch 1.4 Rotation time 0.33 s Acquired images 64 x 0.6 mm

- Reconstructions parameters: B60f 1mm-thick every 0.7 mm, B20f 1mm-thick every 10.0 mm,
B35f 1mm-thick every 0.7 mm, B60f 5mm-thick every 5.0 mm and B35f 5mm-thick every 5.0
mm

At 04:00 PM (T0+8h): PFT will be performed, including vital capacity (VC), forced vital
capacity (FVC), functional residual capacity (FRC), total lung capacity (TLC), residual
volume (RV), forced expiratory volume in one second (FEV1), diffusion lung capacity for
carbon monoxide (DLCO), and alveolar volume (VA) measurements (either in absolute values and
percentage of predicted values). A second CT scan will be performed using the following
technique:

- Supine CT scan after full inspiration.

- Acquisition parameters: (Topogram 35 mA 120 kV 512 mm length) 90 quality ref mAs with
care-dose ON 120 kV Pitch 1.4 Rotation time 0.33 s Acquired images 64 x 0.6 mm

- Reconstructions parameters: B60f 1mm-thick every 0.7 mm, B20f 1mm-thick every 10.0 mm,
B35f 1mm-thick every 0.7 mm, B60f 5mm-thick every 5.0 mm and B35f 5mm-thick every 5.0
mm

Data analysis:

- Emphysema index: from B20f reconstructions, calculation of RA960 using Pulmo CT
software.

- Airway index: from B60f reconstructions (1mm-thick every 0.7 mm), calculations of
luminal area and wall area for several bronchi.

Statistical analyses : Comparisons of CT parameters values or derived values (for example :
wall area to airway area ratio) reflecting emphysema and airways remodelling measured on CT
scans obtained à T0 and T0+8h. Correlations with PFT values and derived values.


Inclusion Criteria:



- age 40 or more

- smoking history > 10 pack-years

- post bronchodilator FEV1/VC < 0.7

- optimal treatment according to GOLD guidelines

Exclusion Criteria:

- COPD exacerbation or infection in the 4 weeks before the study

- concomitant pulmonary disease (tuberculosis, significant bronchiectasis, lung cancer)

- pulmonary resection

- active malignancy or malignancy of any organ system within the past 5 years

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Results of CT Thorax parameters reflecting emphysema and airway remodelling

Outcome Description:

Data analysis: Emphysema index: from B20f reconstructions, calculation of RA960 using Pulmo CT software. Airway index: from B60f reconstructions (1mm-thick every 0.7 mm), calculations of luminal area and wall area for several bronchi.

Outcome Time Frame:

4 hours

Safety Issue:

No

Principal Investigator

Pierre Alain GEVENOIS, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Erasme University Hospital

Authority:

Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Study ID:

AK/10-02-13/3863

NCT ID:

NCT01192932

Start Date:

March 2010

Completion Date:

June 2011

Related Keywords:

  • COPD
  • CT
  • Nycthemeron
  • Emphysema
  • Pulmonary Disease, Chronic Obstructive
  • Pulmonary Emphysema
  • Lung Diseases, Obstructive
  • Airway Remodeling

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